The purpose of this study is to see whether the ICDs(Impulse Control Disorder) are improved and neuropsychiatric traits related to ICD are changed or not when switching dopamine agonist to levodopa/carbidopa in patients with Parkinson's disease who have been treated with dopaminergic medications.

Intervention Model: Single Group AssignmentMasking: Open LabelPrimary Purpose: Treatment

Official Title:

The REmission of the Impulse Control Disorder and the Changes of the Neuropsychiatric Characteristics After Switching Into Levodopa/Carbidopa in Patients With Parkinson's Disease Who Have Developed Impulse Control Disorders Due to the Dopamine Replacement Therapy

PRIMARY OBJECTIVE To evaluate the improvement of mMIDI(modified version of Minnesota Impulsive Disorders Interview,Korean version) score from the baseline to 12 weeks or LOCF(Last Observation Carried Forward)

SECONDARY OBJECTIVE i) To evaluate the improvement of neuropsychiatric profiles from the baseline to 12 weeks or LOCF ii) To evaluate the improvement of UPDRS(Unified Parkinson's Disease Rating Scale)Score from the baseline to 12 weeks or LOCF

Eligibility

Ages Eligible for Study:

30 Years to 80 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient with a diagnosis of idiopathic PD according to United Kingdom Parkinson's Disease Brain Bank Criteria

mMIDI ≥ 3 score with ICD

Patients must be on an anti-parkinson treatment at least 6 months before screening.

for this protocol, dopamine agonists should be included in his/her anti-parkinson treatment.

30years ≤ patients < 80years of age, male or female

patients must give written informed consent before any assessment is performed

Exclusion Criteria:

Requirement of treatment with serious cognitive disorder, behavioral disorder, or mental illness currently or in the future

for the patients ≤ 65years: K-MMSE(korean version of Mini-Mental State Exam) ≤24, or for the patients ≥ 66years: K-MMSE ≤ 20, or the patients have dementia(incl. early dementia) even though K-MMSE score is more than 20

Requirement of treatment more than 6times per day due to the severe motor fluctuation.

Severe dyskinesia

DBS(Deep Brain Stimulation)or any other surgical treatment

History of melanoma or not-diagnostic skin trouble/skin lesions

narrow angle glaucoma

clinically serious surgical or medical condition

malignant tumor

use of other investigational drugs at the time of enrollment within 4weeks

pregnant, nursing or lactating women

women of child-bearing potential

history of hypersensitivity or allergy to levodopa/carbidopa

any serious disease accordidng to the investigator's discretion

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683253